Lumbar Disc Replacement Implant for Posterior Implantation with Dynamic Spinal Stabilization Device and Method

ABSTRACT

The invention consists of disc replacement implant for the lumbar spine designed for insertion into the disc space via a posterior approach. The implant can be stabilized in the disc space by connection to the vertebra or can be connected to dynamic spinal stabilization device consisting of interconnected bullets nested in a spring nested in a woven sleeve. By controlling the limits of elongation and compression the device prevents movement beyond normal physiological limits. In the midrange of movement flexibility is allowed. A method for using the dynamic spinal stabilization device is also provided.

CROSS REFERENCE TO RELATED APPLICATIONS

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BACKGROUND OF THE INVENTION

1. Field of the Invention

The invention relates to a lumbar spine disc replacement apparatus withaccompanying stabilization for the spine and method. The presentinvention is an artificial disc that can be implanted by a posteriorsurgical approach that can be used with devices and methods for dynamicstabilization of spinal vertebrae in a manner that permits motion withinphysiological normal range. The device provides mechanical resistanceand support when the spine attempts to move beyond the desired limits.

2. Description of the Prior Art

Low back pain is an extremely important and costly public health issue,accounting for a significant proportion of the health care costs ofmodem industrialized nations. Conservative or non-operative treatmentprograms are the mainstay of therapy for this condition. This approachincludes physical therapy, exercise programs, cognitive behavioraltherapy, anti-inflammatory medications either orally or by spinalinjection, and by modification in the work place environment andactivities of daily living. Sometimes, however, pain and disabilitypersist and surgical intervention becomes an option.

In general, there are two distinct but overlapping clinical problems,which often occur together. The first is termed sciatica, which iscaused by compression of a spinal nerve either as the result of discprotrusion or bony compression. The second is axial joint pain, whichresults from painful degeneration of the joints of the spinal motionsegment. A spinal motion segment consists of two vertebrae which arejointed together naturally by three joints: the intervertebral disc inthe front of the spine; and the paired symmetrical facet joints in theback of the spine. The surrounding ligaments, tendons and muscle tissuesare also important components of the spinal motion segment.

The surgical treatment for sciatica involves the physical unpinching ofthe compressed spinal nerve by removing the bulging disc or the bonyspurs either alone or in combination. By taking the pressure off of thenerve, the irritation is eliminated and the sensation of pain and/ortingling numbness in the leg is relieved. Hopefully too the loss ofstrength in the affected muscles will also disappear in time. Unpinchinga nerve, however, is not expected to have much affect on any low backpain which may be coexisting.

The surgical option for axial joint pain has traditionally involved alumbar arthrodesis, also known as a fusion. A fusion operation isdesigned to stop and eliminate all motion in the spinal motion segmentby destruction of some or all of the joints of the spinal motionsegment. Bone graft material as well as rigid implanted fixating devicesare employed for this purpose. By eliminating movement at thesymptomatic spinal motion segment the expectation is that the low backpain will be reduced. The disadvantage to this approach is the loss ofspinal flexibility. Additionally some authorities believe that a rigidfusion will place increased stress on neighboring spinal motionsegments, thereby accelerating the degenerative and aging process. Ifthese adjacent motion segments become symptomatic, then additionalsurgical intervention could become necessary on these previously nonsymptomatic areas.

One alternative approach to a rigid spinal fusion is the concept ofjoint replacement, either partial or total. The strategy is similar tojoint replacement surgery in other areas of the body, such as withadvanced degenerative changes in the hips or knees. In the spinal area,this involves the removal of some or all of the joints of the spinalmotion segment accompanied by replacement with a mechanical devicedesigned to replicate the function of the joint that had been removed.

Many examples of devices designed to replace the intervertebral disc orthe facet joints exist. The most common approach to designing artificialspinal discs has contemplated surgical implantation using an anteriorapproach. This procedure requires an access surgeon skilled inmobilizing the large and dangerous blood vessels that obscure the sitefor insertion into the front of the disc. By nature of the anatomy, itis difficult or impossible to see and correct any pinched nerves whenoperating in this approach. Furthermore, extremely accurate placement ofthe artificial disc is essential to allow for the proper functioning ofthe implant. Damage to internal organs in the abdominal cavity, anddamage to small nerves on the front of the spinal column resulting inretrograde ejaculation are additional concerns. Perhaps the greatestdrawback to the anterior approach is the question of dealing withimplant failure or displacement.

Revision surgery in this setting is recognized as extremely dangerousand even life threatening due to the scar tissue that has developedaround the blood vessels located in front of the spine. Mobilizing theseblood vessels the first time when the artificial disc is being initiallyinserted is challenging, especially because of the wide exposure neededto be certain that the disc is correctly positioned. Mobilizing thesesame blood vessels for repeat surgery carries a very high risk ofserious complication or even death. Interference with the circulation tothe lower limbs can have devastating consequences. Massive blood lossfrom tears in the veins stuck down by scar tissue can be fatal. Even ifonly a small number of anteriorly placed artificial discs requireremoval, the percentage of complications is anticipated to beunacceptably high.

For this reason, a posterior approach for implantation of an artificialdisc for the lumbar spine would be preferred by many spine surgeons. Byits nature, this approach permits and even mandates completevisualization of the nerves, so that any compressed neural structurescan be unpinched. Furthermore, the potential abdominal complications,including damage to internal organs, possible retrograde ejaculation,and the risk to the major blood vessels supplying circulation to thelower limbs are avoided.

The main risk of the posterior approach is to the neural elementsthemselves. These include the nerve roots that are exiting the spinalcanal as well as the central grouping of nerve roots called the caudaequina. The risk to these structures occurs during placement andsurgical implantation of the device. Should the implant becomedislodged, move, or migrate, then those structures are again at risk.

The first risk, occurring at the time of surgical implantation, can beminimized in two ways. The first is by the design of the implant, andthe second is proper surgical technique. This requires adequate exposureof the posterior side regions of the disc, so that the implant can beinserted without any damage to the neural elements.

In order to achieve this goal, it is necessary to remove enough of thebony structures covering the lateral regions of the disc. This resultsin the surgical destruction of the facet joints, so that generally facetjoint replacement devices are utilized in conjunction with artificialdiscs implanted using a posterior approach. The second major risk ofthis type of implant is the risk of subsequent dislodgment or migration,which could also damage the neural elements. This hazard is avoided byinsuring that the posteriorly placed artificial disc is firmly attachedand anchored to the vertebral bone.

There are a multitude of patents and patent application Publicationspertaining to artificial disc prostheses designed for implantation viaan anterior or transabdominal approach. However implants intended forposterior insertion in the disc space are not as common. Devicesintended not to replace the entire disc, but only the internal cushionportion called the nucleus pulposus are less technically challenging.Examples of inventions intended to accomplish this limited objective aredisclosed in U.S. Pat. Pub. Nos. 2006/0064172 and 2006/0100304. Shapememory material is inserted through a relatively small opening in theposterior aspect of the outer thick layer of the disc called the annulusfibrosus. The material then expands or uncoils filling the cavity in thecenter of the disc where the nucleus pulposus formerly resided. Thematerial is intended to recreate the cushion or shock absorbercharacteristics of the nucleus. The strong outer ligamentous layer ofthe disc, the annulus fibrosus, continues to provide strength andstability. Furthermore, the facet joints are left undisturbed.

There are several other devices that are designed for partial ratherthan total disc replacement. By partial disc replacement, only the innercomponent called the nucleus pulposus is replaced. However, there areseveral drawbacks to the strategy of partial disc replacement. There isa high risk for displacement or extrusion, since there is no firmanchoring strategy for the implants. For one thing, the degenerativeprocesses that result in the need for surgical intervention rarelyaffect the nucleus pulposus in isolation. Indeed the other components ofthe spinal motion segment joint complex are often similarly affected.Therefore treatment aimed at only part of the problem is likely to beincomplete. There are also issues relating to the geometric specialorientation of the nucleus replacement material, as well as thepotential for later extrusion or displacement of the inserted material.

An approach to total disc replacement is disclosed in U.S. Pat. No.6,419,706 which describes a cylindrical cage designed to screw into theendplates above and below the disc space. It is composed of a metalshell that is divided in two mobile upper and lower halves for anchoringinto the endplates. This metal jacket surrounds a flexible core. Thecore is a “viscoelastic” material—suggestions include a siliconepolymer. This design could be inserted using a posterior approach in thesame manner that cages filled with bone graft material are placed when aspinal fusion is the desired outcome. The problem of extrusion of thecentral core is an issue, as is the shortcomings associated with acylindrical implant. Typically these devices require more retraction andtherefore potential injury to the neural elements, particularly when alarge size is required due to a large disc space with preserved height.This is in contrast to more rectangular shaped implants, where heightcan be increased without increasing width. The other unavoidable aspectof the screw in cylinder design is the destruction of the endplatesnecessitated by the action of the screw threads. This could result insubsidence of the implant with subsequent collapse and narrowing of thedisc space over time with attendant loss of motion.

U.S. Pat. Pub. Nos. 2006/0085073 and 2006/0085074 reveal a deviceintended to replace not only the entire disc but also both paired facetjoint. It contemplates a biocompatible thermoplastic polyurethane orhigh performance nylon “balloons” inflated with a fluid in a closedhydrodynamic circuit. There is a fluid connection not only between therod-like balloons attached to the pedicle screws, but also with theinflatable or expandable element filling the disc space. Loss ofpressurization over time is an obvious concern with respect to thatdesign.

In U.S. Pat. Pub. No. 2006/0085076, there are paired implants placedfrom a posterior direction on either side of the disc space. Each discimplant is composed of two components, which mate with one another byemploying a shallow asymmetrical ball and socket design, which permitssome translation as well as flexion and extension between the twocomponents. Each component is secured to the underlying vertebralendplate with a single angled screw with a recessed head. It is statedthat the surface of the prosthesis can be provided slightly roughened soas to increase bonding of the same with bone and/or one or more surfacecoatings can be provided thereon, such as for example, hydroxyapitite orplasma spray. The posterior elements replacement device is a telescopingarch which is anchored to pedicle screws. The sliding members articulatesomewhat loosely which allows for “small degrees of rotation and side toside flexion.” This design gives the illusion of bending as the rodlengthens. Problems with this design include the potential for posteriorextrusion of the implant. Each half of the paired device is secured onlywith a single bone screw. Additionally there is little to preventdislocation of the shallow ball and socket articulations.

U.S. Pat. Pub. No. 2005/0283247 discloses a design for posteriorartificial discs with the ability to expand the implant after it isinserted into the disc space. A single banana or boomerang shapedimplant is used rather than two symmetrically paired devices. Theexpansion is achieved by a number of different options, including a camshaft design which permits sequential distraction by turning a screwmechanism built into the side of the device. In some of theseembodiments it appears that the expansion may not be readily reversible.The disc replacement prosthesis is intended to be used in conjunctionwith a posterior dynamic stabilization system replicating the functionof the facet joints. The elongated member connecting pedicle screws isconstructed to allow for movement within the pedicle screw heads as wellas a ball and socket joint at the midpoint of the rod, which allows forbending at that point. The mobility at the pedicle screw heads ispermitted by wiggly attachments, either by a mismatch between the sizeof the pedicle screw heads and the rod, or by a mismatch between thescrew heads and a receiving hole in the flat plate-like terminus of therod. It is not disclosed that the rod-like member has the capacity toelastically increase in overall length. An increase in the distancebetween pedicle screw heads is essential if spinal flexion is to occurin a relatively normal fashion with an anteriorly located instantaneousaxis of rotation. An additional potential issue is the difficulty ofplacing a single implant of this shape in the exact center of the disc.Perhaps of even greater concern is the potential for dislocation betweenthe upper and lower element at the ball and socket articulation. It isstated that in some embodiments an “elongated member” may couple theupper and lower elements.

Another expandable design is disclosed in U.S. Pat. Pub. No.2005/0261769. Two metal shells are jacked open and apart using a gearmechanism. Several options for the core element situated between themetal shells are discussed. A drawback with all of these options is thedifficulty that would be encountered in removing the device, shouldrevision and extraction ever be required.

Since posterior placement is preferable to anterior placement, a needexists for a posterior disc replacement implant device that can besecurely positioned without risk of displacement or migration. Thedevice should replicate the primary functions of the disc allowing forflexion, extension, and modest rotation. Furthermore the device shouldbe removable in a safe manner, facilitating replacement or revisionsurgery if it should be required.

It is anticipated that the patient's facet joints will be eitherpartially or totally removed in preparation for implantation of theinvention into the disc space. This is required in order to avoidexcessive traction or damage to the nerve roots during insertion of theinvention, and to permit placement of the attachment shaft in a locationdistant from the nerve roots. For this reason the device according tothe invention is best used with dynamic spinal stabilization system ordevices.

Dynamic spinal stabilization system or devices augment the existingjoints of the spinal motion segment by providing additional strength andsupport by some form of mechanical resistance. The objective is topermit some motion within a physiologic range, yet relieve thesymptomatic painful joints of a portion of the physical stresses. Thesymptoms are improved as the device shares some of the load placed onthe spine and protects against excessive or abnormal motion.Additionally some authorities believe that dynamic stabilization reducesthe probability of accelerated degenerative changes on adjacent motionsegments. Hopefully pain is lessened, flexibility is preserved andfuture problems at neighboring motion segments are reduced. The dynamicstabilization system can also be used in combination with a jointreplacement device.

Spinal deformity is another potential application for dynamicstabilization. Scoliosis, or abnormal curvature of the spine, causes arotational and side bending of the spine resulting in an abnormal shapeand contour of the involved areas. Traditionally a spinal fusionoperation is performed in an attempt to correct the curvature. Analternative approach is dynamic stabilization.

Many types of spinal stabilization devices are known. In U.S. Pat. No.4,448,191 a flat metal band of titanium alloy is attached to the side ofthe spinous processes to exert a chronic dynamic corrective force toreduce the rotational as well as the lateral deformity of scoliosis. Amethod utilizing flexible rods of stainless steel is described in U.S.Pat. No. 4,697,582. Here the rods are also attached to the base of thespinous processes, and the guidance attachments allow axial movement ofthe rod permitting longitudinal spinal growth.

A similar concept for allowing the sliding of long rods either caudallyor cranially is shown in U.S. Pat. Pub. No. 2004/0143264 which utilizessleeves. A design employing springs is provided in U.S. Pat. No.5,672,175. In this design two rods are attached to the spine withpedicle screws, with compression resisting springs on one side andextension resisting springs on the other side. The rods are fixed at themidpoint of the deformity but can slide through the connectors at eitherend—enabling longitudinal growth as well as rotation about anyhorizontal axis. This design also contemplates electronic micromotors toenable adjustment in the tension by moving the position of a stop. Adevice placed anterior to the spine is described in U.S. Pat. No.6,296,643. Plates are positioned along the front of the vertebral bodiesusing bone screws. These plates are then connected using a cable,synthetic ligament, or flexible rod.

Axial joint pain resulting from degenerative changes in the spinalmotion segment is difficult to treat. Sometimes dynamic stabilization isemployed as a stand alone strategy. The concept is that by sharing someof the load, the device relieves the spinal joints of stress and therebyreduces symptoms. Some designs rely on the presence of intact andpreserved anatomic features of the vertebra, such as the midline spinousprocess arising from and projecting back from the lamina of thevertebra. One of the older and simpler concepts is disclosed in U.S. PatPub. No. 3,648,691. A flat strip is clamped to several spinousprocesses. A flexible non-toxic material such as vinylidene fluoride wasstated to be preferable to cast or machined metal straps. In U.S. Pat.No. 5,011,484 a plastic insert is described which fits over and betweenthe spinous processes to restrict but not entirely prevent movement. Thesuggested material is polytetrafluoroethylene with a low frictioncoefficient to facilitate the sliding of the spines of the vertebraeinside the inserts. A semi-flexible intraspinous block is described inU.S. Pat. No. 5,609,632. This design also contemplates a flexibleligament composed of Dacron® (polyethylene terephthalate) wrapped aroundthe spinous processes. In U.S. Pat. No. 6,440,169 a titanium alloy leafspring is placed between the spinous processes, with one variationincluding a solid core of a viscoelastic material such as polyurethaneor silicone.

Another device mounted on the spinous process is detailed in U.S. Pat.Pub. 2002/0095154. This is a design consisting of a compression spring,with another embodiment utilizing a piston/cylinder design and aflexible housing with a gas or liquid working the piston instead of thespring. All of these devices depend on intact spinous processes, andcannot be used when these structures are small or have been surgicallyremoved.

In U.S. Pat. Pub. No. 2006/0084991 a design is presented which is alsoenvisioned to be positioned in part between existing spinous processes,although the inventors state it can also be implanted after laminectomyand removal of the spinous processes. Transverse rods are contoured andbent toward one another to permit location between the spinous processesand also to allow for placement of an articulating joint and/or acentral spacer between the two transverse rods. In addition, elasticelements are used to further join together the transverse rods. It issuggested that the elastic elements could be preferably formed from abiocompatible polymer, such as polyurethane, composite reinforcedpolyurethane, silicone, or other materials.

Another approach to strengthening the spine yet preserving motion is theuse of artificial ligaments. The use of a flexible ligament made fromDacron® attached between pedicle screws is presented in U.S. Pat. No.5,092,866. A more complicated design also intended for use betweenpedicle screws is described in U.S. Pat. No. 5,180,393. Braidedmultifilament yards of retractable polyester are arranged in twoseparate layers: a longitudinal primary layer in a figure-of-8 patterncovered by a transverse secondary winding. The first layer resistsextension and the second layer resists compression. Other conceptsinclude the notion of augmentation of the anterior longitudinal ligamentin the front of the spinal column. A synthetic anterior longitudinalligament composed of ultra-high molecular weight polyethylene in theform or a single strand, cable, tube, or patch is presented in U.S. Pat.Pub. No. 2002/0107524. A mesh design is proposed in U.S. Pat. Pub. No.2002/0120269, with a variety of metal or fiber materials suggested asoptions. A wide range of possibilities mostly involving anteriorflexible bands was revealed in U.S. Pat. Pub No. 2002/0120270. Crosscoupled bands between pedicle screws in an “X” pattern to help preventrotational forces on facet joints, used in association with flexible“dampers” attached to pedicle screws, were disclosed in U.S. Pat. Pub.No. 2002/0133155. Although some flexibility may be permitted by theseligament inventions, elongation is generally prohibited by these designsdue to the inherent lack of elasticity.

Solid flexible members positioned between pedicle screws is anotherdesign consideration. A flat or oval flexible strip composed of carbonfiber reinforced plastic is described in U.S. Pat. Nos. 4,743,260 and5,282,863. A variety of polymers are suggested, and manufacture using areplamineform process is recommended. This results in porosity of thestrip, and it is anticipated that fibroblasts will grow into theseporosities, augmenting its fixation but preserving the flexibility. Asolid flexible rod composed of aromatic polycarbonate-polyurethane basedmaterial such as Bionate® or Chrono-Flex® is suggested in U.S. Pat. Pub.No. 2003/0220642. A titanium rod divided by a flexible joint made of“organic silicone compounds” is described in U.S. Pat. Pub. No.2004/0049189. In U.S. Pat. Pub. No. 2003/0171749, the central portion ofthe rod is divided in half lengthwise. Bending of the rod is permittedonly along the sagittal plane dividing the bifurcated area, thuslimiting bending in other planes. Several flexible rod-like membersconstructed from hollow tubes with slits cut in a spiral pattern arepresented in U.S. Pat. Nos. 6,986,771 and 6,989.011. Two or more tubeswith different spiral patterns are fit snugly one within the other.Tension bands attached to the side of the tubes can provide resistanceto motion. Other embodiments include a solid central flexible rod,braided wire, flexible plastics and rubber based materials. All of theseflexible straight strip, rod, and rod-like designs permit bending, butonce again elongation of the flexible member is not possible. Anotherkind of solid flexible rod is disclosed in U.S. Pat. Pub. No.2005/0277922, in which a molded rod composed of a compressible substancewas surrounded by a molded material resistant to elongation. A largenumber of materials were suggested, including a rubbery polymer for thecompression element and silicone-polyurethane for the tension element.It is unclear how much elongation and bending would result from thiscombination.

A straight and rather large diameter device for use as an elastic“damper” is shown in U.S. Pat. No. 5,540,688. This invention isconstructed of a core material loaded in elongation, and a sleeve orjacket loaded in compression. Three embodiments are presented, and thematerials suggested included a “bio-compatible elastomer.” In contrastto other straight rod-like designs, this invention would permitelongation of the member. However, bending is prohibited, and flexionand extension of the spine apparently depends upon the function of aball and socket articulation with the pedicle screws permitting freepolyaxial movement.

A flexible “U” shaped rod is described in U.S. Pat. No. 5,415,661.Detailed manufacturing options are discussed and the preferredembodiment is identified as a carbon reinforced plastic. Specificallythe carbon fibers are oriented in the optimal alignment and densityusing prepreg tapes, and net compression molding usingpolyetheretherketone as the polymer is employed. The design in the shapeof a “U” would permit elongation between the pedicle screw heads, whichis essential in permitting forward flexion of the spine with arelatively normal instantaneous axis of rotation. Unfortunately thedesign is impractical because of the physical space limitations in theoperative field. The distance between the pedicle screw heads is quitesmall, especially between L5 and S1. Furthermore the anteriorlyprojecting “U” shape would impinge upon the posterior bony structures ofthe spine or the nerve roots. A similar concept involving a more complex“inverted T” shaped bend in a flexible rod is presented in U.S. Pat. No.6,966,910, but suffers from the same limitations.

Various spring designs have been incorporated into inventions designedto preserve motion yet add support to the spine. An invention designedfor use in the front of the cervical spine utilizes a series of leafsprings which resembles an accordion, and is revealed in U.S. Pat. No.6,293,949. A shape memory alloy is suggested as material, andspecifically nitinol is recommended. This is an alloy of titanium andnickel with a low corrosion rate, excellent wear resistance, and minimalelevations of nickel levels in the tissues in contact with the metal.The presence of vital vascular structures makes this device unsuitablefor the anterior lumbar spine. Several designs utilize springs withrod-like members in order to permit elongation and compression of therod, often incorporating a piston and cylinder component. A relativelysimple device is disclosed in U.S. Pat. Pub. No. 2004/0049190 in which arod is surrounded by a spring. The rod is rigidly fixed to one pediclescrew, but sliding is permitted through the attachment to the otherpedicle screw. The rod is coated with ultra-high molecular weightpolyethylene to permit sliding. Either a compression or an extensionspring can be used. Bending of the construct, however, is not allowed. Amodification to permit both elongation and bending is disclosed in U.S.Pat. Pub. No. 2006/0036240. A spring is associated with a telescopingrod with a curved track. With elongation, one component of the rodslides along the curved track permitting an imitation of bending. Atelescoping rod on a curved track without an associated spring ispresented in U.S. Pat. Pub. No. 2006/0085076. The device is meant foruse in conjunction with posterior artificial disc implants. This againpermits elongation or shortening with the illusion of bending.

Another approach to the twin problems of achieving not only lengthvariability but also flexibility is provided in U.S. Pat. Pub. No.2005/0283247. This is designed for use with a posteriorly positionedartificial disc replacement device. The elongated member connectingpedicle screws is constructed to allow for movement within the pediclescrew heads as well as a ball and socket joint at the midpoint of therod, which allows for bending at that point. The mobility at the pediclescrew heads is permitted by wiggly attachments, either by a mismatchbetween the size of the pedicle screw heads and the rod, or by amismatch between the screw heads a receiving hole in the flat plate-liketerminus of the rod.

In U.S. Pat. No. 7,029,475, the device employs compression springs in atelescoping piston system. This invention is adjustable so that maximumresistance to motion in elongation and shortening is achieved in theneutral zone. Outside of the neutral zone the resistance provided by theinvention is less. Bending of the device is not possible, so in order toallow spinal flexion, special mobile articulations with the pediclescrews are required to permit active angular movement at the points ofattachment.

Hydraulic circuits are yet another design concept. In U.S. Pat. Pub. No.2003/0055427, a compression spring and a piston containing a hydrauliccircuit with the reservoirs are placed in the disc space. Bending of thedevice is not permitted, so flexion and extension of the spine onceagain apparently depends upon the function of a ball and socketarticulation with the pedicle screws permitting free polyaxial movement.Yet another design envisioning the use of a complex hydraulic circuit isdisclosed in U.S. Pat. Pub. Nos. 2006/0085073 and 2006/0085074.Inflatable elongated members composed of a type of biocompatiblethermoplastic polyurethane are attached to the spine via pedicle screws.These fluid filled rod-like elements are connected through a closedhydraulic circuit to another inflatable element having the shape of andtaking the place of the intervertebral disc.

An attempt to attain flexibility along with the potential forlengthening and shortening is described in U.S. Pat. Pub. No.2003/0220643. Such a device would not depend upon complex moveablearticulations with the pedicle screws. Several options are discussed.One embodiment contains two concentric springs separated by a rigid orsemi-flexible tube. Another embodiment is an elastic cord surrounded bythe extension block tube. Yet another variation discloses a telescopingflexible tube containing a spring, with the tube composed of a shapememory alloy such as Nitinol, or polyethylene. These designs share thecommon goal of allowing bending and elongation with a stretchableelement, but preventing buckling of the stretchable element with asurrounding tube.

SUMMARY OF THE INVENTION

The lumbar disc replacement implant is designed to fit in the disc spacewith the upper and lower surfaces corresponding to the lens or lozengesilhouette of the disc space found therein. This overall shape is alsoadvantageous for insertion of the implant into the disc space. Theoutline of the implant device according to the present invention canapproximate the outline of implants currently in common use that aredesigned for posterior interbody fusion. The intended purpose of theimplant according to the present invention is to preserve mobilitybetween the spinal bones, rather than to result in a bony fusion betweenthem. As a result of the design, the upper and lower surfaces of theimplant are preferably closely approximated to the endplates of thevertebral bodies on either side of the disc space.

A portion of the implant is fabricated with an anchor shaft whichextends out of the disc space in a manner to allow the anchor shaft toattach directly to the spine by pedicle screws or to a rods attached tospinal stabilization device or devices. The anchor shaft can extend orproject out of the disc space in a generally perpendicular orientationto the vertical plane of the disc space or in an angular fashion fromthe vertical plane of the disc space. The lower half of the implant canbe firmly fixed to the lower vertebra by means of a connection betweenthe anchoring shaft and a pedicle screw, which placed in the pedicle ofthe lower vertebra. This connection can occur directly to the anchoringshaft. Alternatively this connection can occur indirectly through knownintervening coupling mechanisms or spinal stabilization devices whichare connected to the vertebra by a pedicle screw. Some suchstabilization devices, connecting devices and equipment can be obtainedfrom well known medical suppliers such as SCIENT'X USA.

The lower half of the implant may also have projecting fins or ridges inorder to further stabilize the lower half with respect to the innersurface of the endplate of the lower vertebra. The upper mobile half ofthe implant is embedded in the undersurface of the endplate of the uppervertebra as a result of small projections or tooth like protuberances.The upper half of the implant is mobile and can slide up and down aswell as experience small side to side movements with respect to thelower half of the implant. As a result motion between the two vertebraeis facilitated.

According to the present invention, the implant may be fabricated fromany suitable biocompatible metal such as stainless steel or titanium ortitanium alloy. It may also be constructed in whole or in part from anysuitable non metal material, a non limiting example beingpolyetheretherketone PEEK. Gliding surfaces may be fabricated from, orcoated with, any suitable biocompatible material with a low coefficientof friction. A non limiting example is ultra high molecular weightpolyethylene UHMWPE. Additionally, those surfaces designed for contactwith bone may be roughened and coated with substances engineered toencourage in growth of bone at the implant/bone interface. The width ofthe implant can be approximately 10 mm and the length can beapproximately 22 mm or any workable length and width less than thepatient's disc space. The total height of the upper and lower implantcan be approximately 12-16 mm or a height less than or equal to the discspace.

In one embodiment of the invention, the mobility between the upper andlower implant is achieved by means of a guide rail on the lower implant.This embodiment allows sliding of the mobile component along the lengthof the guide rail. The mobile component is in firm contact with and isembedded into the inner surface of the endplate of the upper vertebra.The guide rail is preferably contoured in an arc shape, which replicatesthe normal instantaneous axis of rotation as the upper vertebra movesrelative to the lower vertebra. The opening of the central channel inthe sliding member is cut slightly larger than the guide rail in theanterior aspect of the channel. This somewhat loose fitting permits someside to side motion as well. The individual components of the implantare modular, and can be assembled prior to insertion so the device canbe implanted together. Another option allows for sequential placement inthe disc space with the pieces locking in place. In either technique,the overall assembly is firmly fixed in position by means of direct orindirect connection between the anchor shaft and the pedicle screw.

In this embodiment, these implants are preferably used in pairs, one oneither side of the disc space. Sliding of both of the upper implants ofthe paired implants can occur in the same direction permitting eitherflexion or extension of the spine. Alternatively, sliding of the upperimplants can occur in opposite directions permitting some rotation ofthe upper vertebra in relation to the lower vertebra. Precisepositioning of these paired implants within the disc space is notrequired. This differentiates the device according to the presentinvention from those implants designed for implantation using atransabdominal or anterior approach. The essential aspect of placementfor the paired posterior implants is that the long axis be located inthe sagittal plane of the spine. While symmetry with respect to theabsolute center of the disc of the paired implants is desirable, it isnot mandatory. Furthermore, it is anticipated that the facet joints willbe either partially or totally removed in preparation for implantationof the invention into the disc space. This is required in order to avoidexcessive traction or damage to the nerve roots during insertion of theinvention, and to permit placement of the anchoring shaft in a locationdistant from the nerve roots. For this reason the implant according tothe invention is preferably intended for use with known spinal dynamicstabilization systems or devices.

In another embodiment of the implant, the mobility between the upper andlower halves of the implant is achieved by virtue of a slot or groovewith a corresponding tongue in a slidable tongue and groove joint. Thetongue on the upper mobile half of the implant articulates with slottedgroove on the lower fixed half. The surface of each is preferablycontoured in an arc shape, so that when sliding occurs of the upper halfin relation to the lower half, the trajectory of motion replicates thenormal instantaneous axis of rotation of the vertebrae. In this design,the movement is controlled through a tongue and groove mechanism ratherthan a guide rail and channel design. The individual components of thisembodiment are modular, and can be assembled prior to insertion, or canbe placed in the disc space sequentially with the pieces locking inplace. The overall assembly of this embodiment is firmly fixed inposition by means of either direct or indirect attachment to the pediclescrew in the lower vertebra. The connection occurs between the pediclescrew and the anchoring shaft, which arises from the posterior fixedcomponent of the invention and projects out of the disc space.

In this embodiment as well, these implants are preferably to be used inpairs, one on either side of the disc space. Sliding of the upperimplants can occur in the same direction permitting flexion orextension. Alternatively, sliding of the upper implants can occur inopposite directions permitting some rotation of the upper vertebra inrelation to the lower vertebra. Slight variability between thedimensions of the tongue and groove can achieve some side to sidemovement.

Furthermore it is anticipated that the patient's facet joints will beeither partially or totally removed in preparation for implantation ofthe invention into the disc space. This is required in order to avoidexcessive traction or damage to the nerve roots during insertion of theinvention, and to permit placement of the attachment shaft in a locationdistant from the nerve roots. For this reason the device according tothe invention is intended for use with dynamic spinal stabilizationsystem or devices. The preferred dynamic spinal stabilization system isdescribed herein as the interconnected bullets nested in a spring nestedin a sleeve of woven material connected to the spine by intermediarytransverse rods.

In yet another embodiment of the implant, the front of the implant isrotatable relative to the back part of the implant. The anchoring shaftremains fixed in position and is attached to the lower vertebra througha connection with a pedicle screw in the lower vertebra. The rotation ofthe front part of the implant is intended to occur after the implant hasbeen implanted at an angle to the vertical cross sectional plane of thedisc space. This preferred insertion angle advantageously permitsplacement of the center of the implant into the center of the disc spaceand allows the attachment to the lower vertibra. The surgical techniquefor this placement, which occurs at a more lateral starting pointingfurther from the midline, is termed a transforamenal approach. Thispermits implantation of a larger implant, which is beneficial since thesurface area of the upper implant in contact with the endplate of theupper vertebra will be correspondingly increased. The implantation canbe facilitated by use of known surgical instruments and medical toolssuch as Crescent Instrument Set provided by Medtronic(www.medtronicspinal.com).

The rotational ability of this embodiment of the implant according tothe invention is preferably provided by means of a gear mechanism.Rotation of the front half of the invention is accomplished after theentire assembly is implanted into the disc space, with the center of therotation point at the center of the disc space. The gear mechanism isactuated by turning the head of a rod located at the base of theanchoring shaft, which is located on the fixed or immobile back half ofthe invention. Turning the rod turns a gear which meshes with a largergear that is integrated into the base of the front half of the implant.As a result the orientation of the front half of the implant is changed,whereas the orientation of the back half of the implant remainsunchanged. The objective of the rotation is to align the front half ofthe implant so that the long axis comes to lie within the sagittalplane, which is the plane in which flexion and extension of the spineoccurs.

The front half of this embodiment of the implant according to theinvention contains a sliding element. The movement of the slidingelement is confined to a tract defined by a guide rail or post on thefront half of the implant and the corresponding channel cut through thecenter of the sliding element. This tract has an arc shape, so thatmotion of the sliding element follows an arc like trajectory.

In another embodiment, a tongue and groove design is employed. Since theinner aspect of the endplate of the upper vertebra is attached to thesliding element by virtue of projecting ridges or teeth, the movement ofthe upper vertebra approximates the normal instantaneous axis ofrotation in the sagittal plane. Therefore flexion and extension of thespine is permitted at the spinal motion segment implanted with theimplant. Since the channel cut through the long axis of the slidingelement is larger than the dimensions of the guiding rail or post, someside to side movement as well as slight rotation is permitted.

In contrast to the other embodiments, in this manifestation the implantis preferably intended to be employed as a single device implanted ateach disc space, rather than used as paired implants as previouslydescribed. The implant can be of a larger size, which is possible due tothe technique of insertion in a transforamenal approach. Thetransforamenal approach permits safe passage past the neural elementsduring insertion. Certainly, a transforamenal approach can be also beused for the paired implants, but it is mandatory with the single largerimplant. Location of the single larger implant is optimal in the centerof the disc, but it is not essential. The long axis of the front half ofthe implant should be rotated so that it is in the sagittal plane inorder or allow for flexion and extension movements of the spine. Thiscan be achieved even if the implant is not perfectly centrally located.Therefore placement of this implant is not as critical as those discimplants designed for anterior or transabdominal insertion.

Transforamenal posterior insertion of the single larger rotation-capableimplant according to the invention requires surgical removal of thefacet joint on the side of insertion. For this reason, the implantaccording to the invention is intended for use with known spinal dynamicstabilization systems. Bilateral or in some cases unilateral applicationof the dynamic stabilization system can be considered. When clinicalconditions permit unilateral application, then a mini-open or expandedminimally invasive surgical procedure can be employed for insertion ofthe artificial disc and implantation of the dynamic stabilizing system.

An alternative method of use involves placement of a single non pairedimplant of the rotational post design embodiment together withunilateral placement of a posterior dynamic stabilization system. Sincea one sided surgical exposure is required, implantation couldpotentially be accomplished using mini-open or expanded minimallyinvasive surgical technique. In that method, the facet joint, ligaments,and muscle tissue on the opposite side would be undisturbed. Theinherent stability preserved as a result would justify and validateunilateral posterior dynamic stabilization. Hopefully, the smallersurgical exposure would be associated with a speedier recovery.

The implant can be used with a spinal stabilization system. Thepreferred spinal stabilization allows for flexibility and elasticitywith resistance to buckling and avoidance of excessive buckling. Oneembodiment of the spinal stabilization device consists of interconnectedbullets nested in a spring nested in a sleeve of woven fabric providinga flexible rod-like shape designed to resist excessive elongation andaxial compression, prevent buckling and provide an absolute limit toelongation. Furthermore there is an advantageous bias with respect tothe direction of bending, permitting some desirable control of spinalmovement. It is designed for use with standard pedicle screw systems,and can be connected directly to the spine by the screws or indirectlyto the spine by the screws via intermediary transverse rods.

The dynamic spinal stabilization device disclosed herein may be used ina stand alone application as a load sharing device for the spine,permitting movement within normal limits by what is termed dynamicstabilization. The dynamic spinal stabilization device disclosed hereinmay also be used at the end of a spinal fusion construct to reduce theproblem of juxta-fusional breakdown. The dynamic spinal stabilizationdevice disclosed herein may be employed in association with any discreplacement or disc augmentation technology.

The dynamic stabilization device is flexible in the midrange ofelongation. However the dynamic spinal stabilization device becomesrigid when compressed, which prohibits buckling. At the limits ofelongation, the dynamic spinal stabilization device also becomes morerigid. An absolute limit to elongation is provided.

Special means of articulation requiring mobile joint-like couplingmechanisms, either directly with pedicle screws or indirectly withtransverse rods, are not required. In particular it is not necessarywith the present invention to rely on mobile multi-directionalarticulations with the connecting elements. Standard poly-axial screwsor other rigid and fixed articulations are sufficient. Because of thisability, several practical methods are available which allow forconnection of multiple vertebrae in series if this is required by theclinical setting. An embodiment of the dynamic spinal stabilizationdevice is composed of multiple components arranged in three distinctconcentric layers or tiers, whose mutual interactions provide thedesirable attributes of elasticity and flexibility but only within asafe and predetermined range. The tiers are nested one within the other.A cross-section of the dynamic spinal stabilization device according tothe present invention would reveal the tiers arranged like layers in anonion or rings in a tree. The inner most tier consists of individualinterlocking elements herein termed “bullets.” The shape of the top andbottom sides of the interlocking bullet can be selected based on desiredperformance characteristics for the invention. For example, some designspermit flexibility primarily in only one direction or plane.

The bullets may be made of any suitable material such as titanium, atitanium alloy, stainless steel, and can be coated with a slidingmaterial having a low coefficient of friction such as ultra highmolecular weight polyethylene UHMWPE. Alternatively, the bullets may bemade entirely of any suitable non metal material, an example of whichwould be polyetheretherketone (PEEK). The number of bullets comprisingthe inner most tier is variable and is determined by the desired lengthof the invention. The surgeon can select the most appropriate length atthe time of surgical implantation. Within the inner most tier at eitherend of the series or stack of bullets are the attachment elements, whichserve as attachment points for the invention with the spinal bones. Theattachment elements will be composed of a suitable metal and designed toallow connectivity with existing pedicle screw systems, or alternativearticulating fasteners.

The second or intermediate layer is composed of a spring. In one of theembodiments, an extension spring is utilized, which is designed toresist elongation. The spring may be composed of any suitable shapememory material such as a titanium alloy. The length of the spring inits resting form is chosen so that the individual bullet elements arefully interlocked with one another. This interlocking confers rigidityon the dynamic spinal stabilization device. When tension is applied tolengthen the spring, the individual bullet elements are no longertightly locked, which allows for motion between them and confersflexibility on the invention. The shape and design of the interlockingsection of the individual bullet elements influences the degree anddirection of the flexibility that is permitted, as does the degree ofseparation between the bullet elements which is imparted by elongationof the spring. Graduated resistance to elongation is imparted by theelastic properties of the spring. The length of the stack of bulletsdetermines the length of the spring, and the spring length isapproximately the same as the length of the stacked bullets.

The third or outermost layer in the one embodiment is composed of asleeve of material woven in the form of a Chinese finger trap, alsoknown as a Chinese finger puzzle. The material used could be of anysuitable material including but not limited to braided cable oftitanium, titanium alloy, stainless steel, or a biocompatible non metalsuch as polypropylene, nylon, or other woven fabric. In the resting ornon elongated state of the spring, this outer tier is characterized by asleeve of fabric of a loose weave pattern. As the spring is stretchedand elongated, the weave pattern tightens and the diameter of theoutermost tier constricts around the spring in the intermediate layer.

This constriction confers rigidity on the stabilization device in theelongated state, and the weave pattern is designed so as to provide anabsolute limit on the elongation of the invention at the desired maximumlength. In this fashion, the outermost tier provides some rigidity atthe maximum length as well as a positive stop preventing overstretchingof the spring.

In the combined interactions of the three tiers or layers, the inventionprovides rigidity in the non elongated state, permits bending andflexibility which increases with stretching, but also establishes asafety limit and confers some rigidity which is reacquired at themaximum permitted elongation. The woven fabric is approximately the samelength as the spring. Another embodiment of the dynamic spinalstabilization device is characterized by a fourth layer or tiercomprised of a compression spring, designed to resist shortening of theinterlocking bullets. In this embodiment, the layers or tiers alternatebetween metal and non metal composition, reducing friction and metalwear particle accumulation. In the neutral or resting state of theinvention, the extension spring of the second layer is preloaded in aslight amount of elongation by the force of the compression spring inthe fourth layer. With active compression of the invention, caused byspinal extension or backwards bending of the spine, the individualbullet elements of the innermost tier are interlocked and rigidity isconferred upon the invention. In this embodiment, some degree offlexibility is present in the invention in its resting or neutral state.

In yet another embodiment of the dynamic spinal stabilization device,each of the individual bullet elements of the inner most tier has acurved shape. This results in an overall curved shape of the stackedbullets. This curved shape can correspond to the normal and naturalcontour of the lower spine, which is termed lumbar lordosis. With thecurved shape, the stabilization device provides the possibility forpercutaneous or minimally invasive, surgical implantation of theinvention. This could be accomplished utilizing existing commerciallyavailable instrumentation systems. During minimally invasive placement,increased rigidity of the stabilization could be temporarily orpermanently conferred utilizing a central guide wire, which can bewithdrawn after the invention is successfully positioned within thepedicle screws.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a side view of the rail component of the implant;

FIG. 2 shows a side view of the upper implant;

FIG. 3 shows a cross-sectional view of the upper implant along the linesof 3-3 of FIG. 2;

FIG. 4 shows a cross-sectional view along the lines of 4-4 of FIG. 1;

FIG. 5 shows a side view of the lower implant;

FIG. 6 shows a midbody side cross-sectional view of the lower implantalong the lines of 6-6 of FIG. 5;

FIG. 7 shows a cross-sectional view of the lower implant along the linesof 7-7 of FIG. 5;

FIG. 8 shows a perspective view of the anchor rail embodiment showingthe assembly;

FIG. 9 shows side view of the anchor rail embodiment of the assembledupper and lower implant;

FIG. 10 shows a side view of a lower spine following surgical removal ofthe posterior vertebral elements;

FIG. 11 shows a cross-sectional view of the vertebra along the lines of11-11 of FIG. 10 following surgical removal of the posterior vertebralelements;

FIG. 12A shows a side view of placement of lower implant in disc space;

FIG. 12B shows a side view of placement of upper implant in disc space;

FIG. 12C shows a side view of placement of upper implant in disc space;

FIG. 12D shows a side view of placement of anchor rail in disc space;

FIG. 12E shows a side view of placement of guide rail and anchor postwithin the upper implant in the disc space;

FIG. 12F shows a side view of completely assembled implant in discspace;

FIG. 13 shows a perspective view of the upper implant and lower implantof the tongue and groove embodiment;

FIG. 14 shows a side view of the tongue and groove implant;

FIG. 15 shows side view of the upper implant;

FIG. 16 shows a cross section view of the upper and lower implants withone embodiment of the tongue and groove joint along the lines of 16-16of FIG. 14;

FIG. 17 shows a cross section view of the upper and lower implants alongthe lines of 16-16 of FIG. 14 with an alternative embodiment of thetongue and groove joint;

FIG. 18A shows a side view of placement of the upper implant of thetongue and groove embodiment in the disc space;

FIG. 18B shows side view of placement of the lower implant of the tongueand groove embodiment in the disc space;

FIG. 18C shows side view of placement of the upper and lower implants ofthe tongue and groove embodiment in the disc space;

FIG. 18D shows side view of the assembled upper and lower implant of thetongue and groove embodiment in the disc space;

FIG. 18E shows side view of the assembled upper and lower implant of thetongue and groove embodiment in the disc space;

FIG. 19 shows the top cross-sectional view of spinal vertebra;

FIG. 20 shows the top cross section view of a pair of assembled implantsin the vertebra's disc space;

FIG. 21 shows a posterior view of the lower spine with a number ofimplants attached to a dynamic spinal stabilization system;

FIG. 22 shows a side view of the rotational post implant;

FIG. 23 shows a top view of the rotational post implant;

FIG. 24 shows a cross section view of the rotational post implant;

FIG. 25 shows a cross section of the upper implant of the rotationalpost implant along the lines of 25-25 of FIG. 24;

FIG. 26 shows a top view of the rotational post implant in the discspace;

FIG. 27 shows a perspective view of the engagement of the gearmechanism;

FIG. 28 shows a top view of the rotational post implant in the discspace.

FIG. 29 shows a side perspective view of the dynamic spinalstabilization device's inner most or first layer in a state ofelongation at greater than maximum length;

FIG. 30 shows a side perspective view of the dynamic spinalstabilization device's middle or second layer of the invention in astate of elongation at greater than maximum length;

FIG. 31 shows a side perspective view of the dynamic spinalstabilization device's outer or third layer in a state of elongation atgreater than maximum length;

FIG. 31A shows a side perspective view of the dynamic spinalstabilization device's fourth layer in a state of elongation at greaterthan maximum length;

FIG. 32 shows a side perspective view of the dynamic spinalstabilization device's inner or first layer in the neutral or restingstate at minimum length;

FIG. 33 shows a side perspective view of the dynamic spinalstabilization device's middle or second layer in the neutral or restingstate at minimum length;

FIG. 34 shows a side perspective view of the dynamic spinalstabilization device's outer or third layer in the neutral or restingstate at minimum length;

FIG. 35 shows a side perspective view of one embodiment of an individualbullet element from the inner or first layer of the dynamic spinalstabilization device, termed the cone shaped design;

FIG. 36 shows a side perspective view of another embodiment of anindividual bullet element from the inner or first layer of the dynamicspinal stabilization device, termed the curved hook design;

FIG. 37 shows a side perspective view of another embodiment of anindividual bullet element from the inner or first layer of the dynamicspinal stabilization device, termed the flat arrow design;

FIG. 38 shows a cross-sectional view of the inner or first layer of thedynamic spinal stabilization device in a resting state of minimallength;

FIG. 39 shows a cross-sectional view of the inner or first layer of thedynamic spinal stabilization device in a state of elongation andflexible bending;

FIG. 40 shows a cross-sectional view of the inner or first layer of thedynamic spinal stabilization device with individual bullet elements of adesign shown in FIG. 8 seen in a resting state of minimal length;

FIG. 41 shows a cross-sectional view as in FIG. 40 but in a state ofelongation and flexible bending in the permitted direction;

FIG. 42 shows a cross-sectional view as in FIG. 40 also in a state ofelongation but with only slight flexible bending in other than thepermitted direction;

FIG. 43 shows a side view of the guide wire;

FIG. 44 shows a cross-sectional view of the inner or first layer of thedynamic spinal stabilization device composed of individual bulletelements similar to FIG. 40 but designed with a curved shape. The guidewire is seen inserted through a channel located in the center of thelong axis of each curved individual bullet element;

FIG. 45 shows a cross-sectional view to FIG. 44 but with the guide wireremoved, the invention in a state of elongation and flexible bending inthe permitted direction;

FIG. 46 shows a cross-sectional view taken along line 46-46 of FIG. 45.

FIG. 47 shows a perspective view of multiple devices connected to thespine via pedicle screws;

FIG. 48 shows a perspective view of an arrangement of multiple dynamicspinal stabilization devices connected to the spine indirectly viapedicle screws using intermediary transverse rods;

FIG. 49 shows a perspective view of an arrangement of multiple dynamicspinal stabilization devices connected to the spine indirectly viapedicle screws using intermediary transverse rods;

FIG. 50 shows a perspective view of paired plates for connecting thedynamic spinal stabilization device to either side of the spinousprocess of a vertebra;

FIG. 51 shows a perspective view of another embodiment of the pairedplates for connecting dynamic spinal stabilization devices to eitherside of a spinous process of a vertebra;

FIG. 52 shows a perspective view of the attachment of the paired platesand dynamic spinal stabilization device to a spinous process;

FIG. 53 shows a perspective view of paired plates and paired dynamicspinal stabilization devices linking two contiguous spinous processes.

FIG. 54 shows a side view of the dynamic spinal stabilization deviceattached to two contiguous spinous processes;

FIG. 55 shows a side view of the dynamic spinal stabilization deviceattached to three contiguous spinous processes.

DETAILED DESCRIPTION

Certain exemplary embodiments are described to provide an overallunderstanding of the principles of the structure, function, manufacture,and use of the devices and methods disclosed herein. One or moreexamples of these embodiments are illustrated in the accompanyingdrawings. Those skilled in the art will understand that the devices andmethods specifically described herein and illustrated in theaccompanying drawings are non-limiting exemplary embodiments and thatthe scope of the present invention is defined solely by the claims. Thefeatures illustrated or described in connection with one exemplaryembodiment may be combined with the features of other embodiments. Suchmodifications and variations are intended to be included within thescope of the present invention.

The implant is presented in several exemplary but non limitingembodiments. The first embodiment is identified as the anchor raildesign. It is comprised of 3 separate components, which fit together ina unified construct. In FIGS. 1-9 the individual components or elementsare shown. In FIG. 1, the anchor rail 18 is composed chiefly of theanchor shaft 20 and the guide rail 21. The top 30 of the anchoring shaft20 can be attached to known polyaxial articulating device similar tothose found on multi-axial pedicle screws. The guide rail 21 preferablyhas a curved or scimitar design, and is thicker than it is wide. In oneembodiment, it is constructed with slightly rounded ends 17 as shown inFIG. 4. In FIG. 5, the lower implant 22 is shown. The top surface 32 ofthe upper implant 23 has a curved shape corresponding to the innersurface 12 of the upper vertebral endplate as shown in FIGS. 12A-12F.The lower implant 22 is shown having a smooth dome shaped surface 24,which is intended to articulate with and support the sliding of thebottom surface of the upper implant 23. This articulation between theupper implant 23 and lower implant 22 provides additional support to theupper implant 23 so that some of the support and sliding stress isshared with the post 21. In FIG. 6, a front indentation or receptacle 25on the lower implant 22, is designed to snugly and securely receiveprojections 29 located on the end of guide rail 21 and in FIG. 6, a backindentation or receptable 26 on lower implant 22 receives the midbodyprojection 29 on the guide rail and anchor post 18. On the bottomsurface of the lower implant 22 are shown projecting fins or ridges 31,whose purpose is to further stabilize the lower implant 22 with respectto the lower vertebra. In FIG. 5 the contour of the lower surface 19 ofthe lower implant 22 is designed to match the contour of the innersurface of the lower vertebra upon insertion of the implant.

In FIG. 3, the upper implant 23 is constructed with a central cavity orchannel 27, which is slightly larger in cross sectional diameter thanthe post 21. In one embodiment, the central channel 27 is trapezoidal incross-section, permitting some side to side motion of the upper implant23 with respect to the post 21. In FIG. 4, the cross section of theguide rail 21 shows the shape of guide rail. The top surface 32 of theupper implant 23 is designed to contour to the inner surface the uppervertebra having projecting fins or ridges 33.

In FIGS. 10 and 11 and FIGS. 12A-12F, a multi-step method is illustratedfor the sequential assembly of the three separate components of the postdesign embodiment of the present invention performed within the discspace. Alternatively, this assembly may be completed outside of the discspace, and the three components 22, 23, and 18 inserted simultaneouslyafter the dimensions of the disc space have been determined and preparedwith progressive trial implants. The separate component design of thisembodiment allows for implantation of a device of appropriate size, sothat the device closely approximates and tightly binds with the innersurfaces of the endplates of the upper and lower vertebra on either sideof the disc space. It is anticipated that the main variability in theassembly will involve selection of upper implants 23 of varying heights.This height variability will result in increasing or decreasing distancebetween the post 21 and the anterior surface of the upper implant 23. Inthis fashion, the upper implant of appropriate size can be chosen toinsure a tight fit within the disc space resulting in optimum binding ofthe invention with the endplates with respect to the lower vertebra 38and of the upper vertebra 39.

In FIGS. 10 and 11, the posterior vertebral elements, including thespinous process 130, lamina 132, inferior articulations process 134 andpars interarticularis 136 are surgically removed. The disc is nextremoved. Removal of the posterior vertebral elements is to provideaccess to the disc space and to minimize surgical trauma to spinalnerves. For sequential insertion of the anchor rail embodiment of thepresent invention, it is advantageous to place the lower implant 22first, and the anchor rail 21 last. The upper implant 23 can be insertedtogether with the lower implant 22 or separately. The orientation of thespine and the upper implant 23 is maintained in neutral position,without flexion or bending of the spine during placement of the anchorrail 18. For placement, a holder/inserter tool 35, with side arms graspsthe lower implant 22 as well as a portion 36 of the upper implant. Theupper implant can have indentations 15 on its sides to facilitategrasping by the holder/inserter tool 35 also shown in FIG. 8 and FIG.12C. Once assembly is complete, the holder/inserter tool 35 iswithdrawn.

Another embodiment of the present invention is termed the tongue andgroove design, and is presented in FIGS. 13 and 14. The slot design iscomprised of a slotted lower implant 40 and upper implant with tongue41. The slotted lower implant 40 is attached to an anchoring shaft 70.The top 71 of the anchoring shaft 70 can be attached to the spine byknown multi-axial articulating structures similar to those utilized oncommercially available polyaxial pedicle screws available from surgicalsuppliers such as Medtronics and SCIENT'X USA (www.scientxusa.com). Theupper implant 41 with tongue 42 articulates with the slotted lowerimplant 40 by means of a type of tongue 42 and groove 47 joint. Theslotted lower implant 40 preferably has a curved surface 43 on whichslides along the upper implant 41 with tongue 42. Slot 47 alsopreferably has a curved surface 72, corresponding to the curved surfaceof the end of the tongue 42. The front edge 45 and back edge 44 of theslotted lower implant 40 are shaped as positive stops. There can be asmaller positive stop 49 at the inferior aspect of the slot 47 since apartial continuation of the slot 47 is provided by inferior groove 46.The inferior groove 46 is designed to permit sequential assembly to thelower implant and the upper implant within the disc space. The positiveback edge stop is provided by the outer surface of the back edge 44 andthe back edge's smaller inner surface 49. The distance of approximately2 cm between the positive stops 49, 44 and 45 on the top of lowerimplant 40 can limit the distance the upper implant slides and limit theamount of mobility between the upper and lower implant. The top surfaceof upper implant 41 has ridges or projection 73 for attachment to theupper vertebra and the bottom surface of lower implant 40 has ridges orprojections 74 for attachment to the lower vertebra.

FIGS. 16 and 17 provide cross-section views of two embodiments of theupper implant with tongue 41. Specifically different configurations ofthe tongue 42 and complimentary groove 48 are shown. In one embodiment,a tight fit is shown in FIG. 16 between a rectangular tongue 42 andgroove 48. This particular configuration would insure a more controlledmovement permitting limited, if any, side to side movement with respectto the upper implant and lower implant. In FIG. 17, an alternativeembodiment is shown where the groove 48 has a more rounded through shapewhich together with the curved posterior aspect of the tongue 42 ofupper implant 41 permits a greater amount of freedom for side to sidemovement and rolling of the upper implant in relation to the lowerimplant. In these embodiments, the upper implant may not be permanentlyattached to the lower implant 22. Prevention of displacement ordislocation of the upper implant 41 with the lower implant 40 is insuredby the tight fit and the contour of the disc space. Another embodimentis one in which the tongue and groove is “T-shaped” which would resultin a more secure attachment of the upper implant and further reduce thealready low probability of upper implant displacement or migration. Theanchor rail design embodiment of the present invention absolutelyprevents displacement or migration of the upper implant, since in thatembodiment the upper implant is confined to a track defined by the postor guide rail and the central channel.

FIGS. 18A-18E show a multi-step process is illustrated for thesequential assembly of the two separate components of the tongue andgroove design embodiment of the implant performed within the disc space.Alternatively, this assembly may be completed outside of the disc space,and the two components inserted simultaneously after the dimensions ofthe disc space can be determined such as by progressive trial implants.The separate component design of this embodiment allows for implantationof a device of appropriate size, so that the device closely approximatesand tightly binds with the inner surfaces of the endplates of the upperand lower vertebra on either side of the disc space.

The body of the lower implant should fit in a typical disc space and canbe approximately 2.5 cm in length and the upper implant can beapproximately 1 cm to 1.5 cm in length with a total height of theassembled implant at 9 mm to 14 mm. The anchor shaft's length isapproximately 15-20 mm and the width of the implant is approximately 10mm or any workable length and width less than the patient's disc space.It is anticipated that the main variability in the assembly will involveselection of upper implants 41 of varying heights within the parametersof the size of the disc space. In this fashion, an upper implant ofappropriate size can be chosen to insure a tight fit within the discspace resulting in optimum binding of the invention with the endplatesof both of the vertebrae. For sequential insertion of the slot designembodiment of the present invention it is advantageous to place theupper implant 41 first, and the lower implant 40 next. The upper implantcan be inserted together with the lower implant or separately. In anyevent it is important to maintain the orientation of the upper implantin a neutral location during placement of the lower implant. This properplacement can be insured by a holder/inserter tool 55, with side armsthat can securely grasp the upper implant 41. As shown in FIGS. 18 A-B,the lower implant 40 is attached to an implant tool 75 and inserted intothe disc space and tongue and groove joint is engaged. Once assembly iscomplete, the holder/inserter tool and implant tool are withdrawn.

In FIGS. 20 and 21, a pair of assembled implants 82 and 83 are shownwithin the disc space and affixed to a transverse rod 84 and thetransverse rod 84 is secured to by pedicle screws 85 to the vertebra 86.The rods should be sized to fit within the patient's transverseprocesses 140 with approximately 5-6 cm in length with width sufficientfor attachment by pedicle screws.

Another embodiment of the implant according to the invention isdisclosed in FIGS. 22, 23 and 24. This embodiment is referred to as therotational post design. The lower implant has a lower section 95 thatincludes the anchoring shaft 97 and main body 60 in which is found theturnable axle 65 terminating in a small gear 64 and an upper section 96.The upper section 96 of this embodiment is comprised of the largerrotating gear and axle 63. The upper implant 67 can slide along a tongue62 of the upper implant within grooves 77 in the upper section 96 of thelower implant. Different upper sections and upper implants 67 of varyingheights would enable selection of a size compatible with the dimensionsof the disc space. The implants are preassembled in this particularembodiment and can be inserted as a unit, after the disc space has beenmeasured and prepared with a series of known temporary trial inserts.During the insertion process, the assembly can be secured with aholder/inserter tool, which can insure a correct neutral position of theupper implant 67 on the post 62. Once the implant is placed, theholder/inserter is removed and withdrawn. The head 30 of the anchoringshaft 20 is connected either directly or indirectly to a pedicle screwor stabilization device such as transverse rods 84 and dynamicstabilization rods that is placed independently in the pedicle of thelower vertebra. After placement in the disc space, the upper section isrotated with respect to the lower section as shown in FIGS. 27 and 28.The rotation is accomplished by turning the axle 65 until the lowerimplant is parallel and coplanar with the sagittal plane of the discspace and the adjoining vertebra. Correct orientation can be documentedusing X-ray fluoroscopy. When rotation is complete the orientation issecured by means of a locking screw 66. The anchor shaft 97 is attachedto the pedicle 150 of the spine by pedicle screw 20. FIG. 28 showsimplantation after removal of one facet of the spine. In this fashionflexion and extension of the spine in the sagittal plane is permitted.Similar to the tongue and groove embodiment, the configuration of thepost and the central channel through the upper implant can be designedto allow for some side to side and rotational movement of the uppervertebra with respect to the lower vertebra. Should removal of theimplant be required in the future, the implant according to the presentinvention advantageously allows for derotation of the upper implant.This is accomplished by removal of the locking screw 66 and turning theaxle 65 connected to the small gear 64 in the direction opposite to thatused during implantation. After the orientation of the upper section isrealigned with the lower section, extraction of the entire assembly isfacilitated.

The rotational post design is preferably larger in overall dimensionsthan either the simple post design or the slot design embodiments.Additionally as shown in FIG. 28, the rotational post design ispreferably for solo use in the disc space. In contrast the simple postdesign or the slot design is preferably for paired usage at each discspace as shown in FIG. 10. In all cases, however, the embodiments sharethe common design characteristic of stable positioning of the implant asa result of the connection between the anchoring shaft 20 and a pediclescrew 80. In the simple cross-sectional view of FIG. 28 a directconnection to the pedicle 81 is illustrated.

A representation of one potential method of indirect attachment andincorporation of an embodiment of the dynamic spinal stabilizationdevice is shown in FIG. 21. Stabilization of both the L4-5 and the L5-S1disc spaces is revealed. In this non limiting example, paired simplepost or slot devices are utilized. FIG. 10 shows the lower lumbar spinehaving vertebra L-3 140, L-4 142, L-5 144 and the sacrum 146 withremoval of the posterior elements.

As has been previously stated, these embodiments require a laminectomyand at least partial and usually total removal of the posteriorvertebral elements as shown in FIGS. 10 and 11. For that reason, thedevices according to the present invention should be utilized inconjunction with a posterior dynamic stabilization system. Oneembodiment of the dynamic spinal stabilization system can includevarious straight transverse members 112 and curved transverse members114 attached to the spine 120 by pedicle screws 118 and the membersattached to the anchor posts 97 of implants in the disc spaces withflexible rods 116 attached to the members 112 and 114 providing dynamicstabilization to the spine as shown in FIG. 21.

The paired implants according to the present invention are seen in theL4-5 disc space 91 and the L5-S1 disc space 92. The connection betweenthe anchoring shaft and the transverse members and to the flexible rodsmay be achieved through a variety of known means. As previously stated,it is anticipated that the top of the anchoring shaft 97 will be fittedwith a multi-axial head similar to those found on commercially availablepolyaxial pedicle screws.

An embodiment of the dynamic spinal stabilization device is compromisedof three layers or tiers arranged concentrically and nested one withinthe other culminating in a general rod-like shape. Cross-section of thedynamic spinal stabilization device would reveal the tiers to bearranged like the layers of an onion or the rings in a tree. The innermost or first layer is shown in FIGS. 29 and 32, in which the individualbullet elements, 220, 221, 222, 223 have the form and shape shown inFIG. 35. In FIGS. 29 and 32 are shown four individual bullet elements,220, 221, 222, 223 but a greater or smaller number may be employedwithout departing from the spirit and scope of the invention. Thebullets are 3-5 mm in length forming a rod that can be 12-30 mm inlength depending upon the number of bullets. As those skilled in the artcan readily appreciate, it is desirable to be able to select from anassortment of rod-like shapes of differing lengths based upon thespecific anatomic requirements of the surgical implantation. Thesebullet elements may be made from any suitable material, including butnot limited to ultra high molecular weight polyethylene UHMWPE,polyetheretherketone PEEK, or a metal such as a titanium alloy coatedwith a material with a low coefficient of friction such as UHMWPE.

Each of these bullet elements has an upper side 227 as well as a lowerside 228 that allows for an interconnected stack series of bullets, 220,221, 222 and 223 with the upper side 227 fitted into the adjacentbullet's lower side 229. Other embodiments can confer differentflexibility characteristics on the dynamic spinal stabilization device,and would not depart from the spirit and scope of the invention.Additionally at the bottom end of the stacked bullets 220, 221, 222, 223is a bottom attachment element 231, and at the top end of the stackedbullets is a top attachment element 232. The bottom attachment element231 has an upper side 218 for insertion into a compatible lower side 229of bullet 220. The top attachment 232 has a lower side 217 forming acavity sized to receive the upper side 229 of the adjacent bullet 223.The individual components of the inner tier, which include the twoattachment elements, 231 and 232 and the intervening bullet elements220, 221, 222, and 223 interconnect with one another when the stack ofbullets are resting at minimum length without elongation shown in FIGS.32, 33 and 34. Because of this interaction or interconnection of theupper 227 and lower sides 229, the stacked bullets 220, 221, 222, and223 with the top attachment 232 and bottom attachment 231 becomegenerally rigid, and little to no flexibility shown in FIGS. 32, 33, 34,38, 40 and 45. However, when the stacked bullets 220, 221, 222, and 223are separated by elongation as a result of applied longitudinal tension,the individual bullets 220, 221, 222, and 223 of the inner tier nolonger fully interconnect with each other. This elongation of thebullets 220, 221, 222, and 223 is shown in FIGS. 29, 30, 31, 39, 41, 42and 45. As a result, angular movement can occur between the individualbullets 220, 221, 222, and 223 and attachment elements 231, 232 and somedegree of flexibility is imparted to the dynamic spinal stabilizationdevice as shown in FIGS. 39, 41 and 45. The attachment ends are sized tobe compatible with the attachment means such as sized to fit a pediclescrew. The diameter can be ¼ inch or 5/16 inch. The bullets can bealternatively flexibly attached or connected together by tethersattaching adjacent bullets. A tether 215 can allow flexible connectionof the bullets and provides for a terminal elongation of the bullets.The tether 215 should be made of suitable durable material forimplantation such as a braided titanium cord. Alternatively, the bulletscan be flexibly attached by other material such as strips of fabric,metal or plastic attaching the bullets to each other in a flexiblemanner limiting complete separation of the bullet elements.

The shape and design of the individual bullets influence, direct anddictate the amount and direction of flexibility permitted after theinitial elongation of the invention. In particular, the shape and designof the upper side and lower side are responsible for this property ofthe invention. Three exemplary but non-limiting embodiments of thebullets are presented in FIGS. 35, 36 and 37. In FIG. 35, a cone-likedesign for the upper side 237 of bullet 236. In FIG. 36, the bullet 238,has an upper side forming a curved hook or quarter cylinderconfiguration 239 with a bottom side ledge 243. In FIG. 37, the bullet240 has “flat arrow” design for the upper side 242. Designs orconfigurations of the upper side of the bullets or the shape of thebullets other than those shown would not depart from the spirit or scopeof the invention. Each bullet has a correspondingly designed lower side244, 246 and 248 which permits insertion and interlocking withcomplementary upper side 237, 239 and 242 respectively of an adjacentbullet.

The flexibility permitted by the cone design is shown in FIG. 39. Whenin the resting state at minimum length, the individual bullets of theinner tier are interlocked and the inner tier is generally rigid whenthe collar 250A at the base of the cone is fully inserted in theadjacent bullet lower side cavity 244.

The stacked series of bullets and attachment elements can be secured tothe patient's spine by attachment means such as pedicle screws that areaffixed to the attachment elements, and when flexion of the spine isattempted, the distance between the pedicle screw heads is increased.This flexion produces longitudinal tension between the attachmentelements resulting in an unlocking and separation of the bulletelements. Increased flexion results in a widening gap between the upperends and lower ends of neighboring bullet elements. As can be seen inFIGS. 39, 41 and 45, this permits angular flexibility between the bulletelements 220, 221, 222, and 223 resulting in bending of the bullets withrespect to each other. In an embodiment with the cone shaped design 237being symmetrical, bending of the bullets 220, 221, 222, and 223 in allplanes is equally permitted. The bullets 220, 221, 222, and 223 in theresting state resist buckling with reverse bending of the spine, calledextension. In this manner, bending of the bullets and therefore of theinvention as a whole is allowed with spinal flexion, but resisted withspinal extension.

Limited flexibility permitted by the curved hook design 239 is shown inFIGS. 39, 40 and 41. When in the resting state at minimum length, theindividual bullets 220, 221, 222, and 223 are stacked and interlockedand the inner tier stack of bullets are generally rigid. When flexion ofthe spine is attempted resulting in movement of the two vertebra, thedistance between the pedicle screw heads attached to the bottomattachment element 231 and the top attachment element 232 is increased.This produces longitudinal tension between the top attachment element232 and bottom attachment element 231 resulting in a separation of thecurved hook 239 and the lower side 246 of the bullet elements 220, 221,222, and 223. Further elongation of the stacked bullets 220, 221, 222,and 223 results in a widening gap between the upper and lower componentsof neighboring bullet elements. As can be seen in FIGS. 41 and 42 thispermits angular flexibility between the bullet elements resulting inbending of the inner tier of stacked bullets. The shape, size and designof the upper side 239 and lower side 246 generally restricts motion andlimits bending of the stacked bullets except in a plane parallel to itscurved surface of upper side of the curved hook 239 and in a directionopposite to its curved surface. In particular a downward bending may bepermitted as in FIG. 41, which corresponds to spinal flexion. Upward orreverse bending is resisted even with elongation of the invention asshown in FIG. 42. Therefore spinal extension is restricted. Side to sideor lateral bending of the stacked curved hook bullets is restricted.This type of movement would be permitted after elongation with the conedesign 237. However, the curved hook design restricts side to side orlateral bending because of the flat shape of the sides of the upper 239and lower 230 components of the curved hook bullet element. Flexibilityand bending is possible only in a plane parallel to the curved surfaceand in a direction opposite to that curved surface.

Another aspect of the curved hook design is the downward projectingledge 243 and its corresponding lower edge 247 of the opening of thelower side 246 of the adjacent bullet to prevent the hook fromcompletely separating from the cavity of the lower side 246. These twofeatures functioning together encourage an even and constant spacingbetween the individual bullet elements as the invention is elongated andthe distance between the two end attachment elements is increased.Otherwise, it is possible that the distance between bullet elementscould vary too much, resulting in uneven and patchy flexibility of theinvention. Several bullets might remain stuck together and interlocked,with all of the separation occurring between only a few of the bulletelements. The hook design 239 advantageously encourages a more evenspatial distribution of the bullet elements as the dynamic spinalstabilization device is lengthened.

An alternative embodiment utilizes a central guide wire 252 of lengthsized to pass through all bullets disposed through the individual bulletelements within a central passage or canal 55, placed down thelongitudinal axis of each bullet 256 in order to achieve a more evenspatial distribution. The central guide wire 252 can be permanently ortemporarily placed in this central passage 255 through each bulletelement as well as through each attachment elements 231 and 232 therebyconferring additional rigidity on the assembly. The guide wire 252 canbe attached to the bullets by threaded screw attachment or otherattachment means such as clasp, hook or locking nut.

The guide wire 252 can rigid or flexible and is made of a suitablematerial for implantation such as titanium alloy. The guide wire canhave a shape memory quality. The length is governed by the size andnumber of bullets. The guide wire 252 can have some rigidity to impartrigidity and flexibility to the bullets depending upon the amount offlexibility or rigidity of the wire.

Another bullet 240 embodiment has a flat arrow upper side 242 as shownin FIG. 37 having two opposite sides 257 tapering to a narrower distalend and two remaining sides 259 are flat and generally parallel. Thisshape of the upper side 242 permits the relatively free movement in upand down bending similar to the cone shape along the tapered sides, buttends to restrict side to side bending along the flat sides in a manneranalogous to the curved hook design 239. Although upward bending ispossible with coincident elongation, no upward; bending would bepermitted with compression of the invention. That is a result of theinterlocking of the individual bullet elements which resist bending inthe compressed state. Extension of the spine results in and is possibleonly with a decrease in the distance between the upper posterioraspects, also called heads, of the pedicle screws 216. This would resultin compression of dynamic spinal stabilization device, since the dynamicspinal stabilization device is attached at each end either directly topedicle screws 216 or indirectly to transverse rods 254 which themselvesare attached to pedicle screws 216. Since spinal extension would occuronly with compression of dynamic spinal stabilization device, anyextension resulting in compression of the dynamic spinal stabilizationdevice past its fully compressed state would be resisted. The dynamicspinal stabilization device according to the present invention thereforehas an important structural advantage over many other dynamicstabilization devices. Due to the interlocking of the bullet points atthe point of minimum length, buckling would be resisted.

Many other design variations and embodiments are possible withoutdeviating from the spirit and scope of the invention. For example, acontoured design of the bullets 256 is presented in FIGS. 44 and 45.Each individual bullet 256 is curved so that the stacked bullets have acurved rodlike shape in the resting or neutral and nonelongated state.Therefore the stack of bullets in this embodiment can have a shape whichcan correspond to the normal curvature of the lumbar spine, which istermed lumbar lordosis. Therefore the bullets 256A, 256B, 256C, and 256Drevealed in FIGS. 44 and 45 are described as the “curved hook” design.This particular design has the same bending and movement characteristicsas the curved hook design. In particular, flexibility in one plane isadvantageously permitted. This lordotic shape and temporarily increasedrigidity would permit percutaneous or open minimally invasive surgicalimplantation. Once the dynamic spinal stabilization device is placed andsecured in the pedical screw heads, the guide wire can be withdrawn.

Additional design embodiments for the upper and lower components of thebullet elements are possible without departing from the spirit or scopeof the invention. For example, an upper side shaped like a cone withflat sides would restrict side to side bending. Upward bending would bepossible, but with spinal extension the pedicle screw heads move closertogether. This movement compresses the invention, causing the individualbullet elements to interlock and conferring rigidity on the invention.Therefore spinal extension is resisted and buckling of the invention isprevented. Spinal flexion would be allowed in association withelongation of the invention. The distal end of the arrow is wider thanthe middle forming winged edges 213 and a corresponding lower surface ofan adjacent bullet can be designed which would allow combined smoothfunctioning of the assembly. These winged edges 213 contact a ridge 211in the cavity of the bottom side of the adjacent bullet preventing thearrow from separating out of the cavity.

The dynamic spinal stabilization device can have a middle orintermediate layer or tier. This tier is composed of an extension spring262, shown in FIGS. 30 and 33. This extension spring 262 can bemanufactured from any suitable shape memory material, including but notlimited to a titanium alloy of size and length to encase the bullets.This extension spring 262 is designed to resist elongation, and has aresting or neutral length that results in the individual bullet elements220, 221, 222, and 223 closely approximated with firm interlocking ofeach upper side with its corresponding lower side. In this manner,rigidity is conferred on the invention in the neutral or resting length.Springs are inherently flexible, and will reflect the amount and degreeof flexibility allowed by the stacked bullets 220, 221, 222, and 223which is composed of the individual bullet elements and the two endattachment elements. The only resistance provided by the spring 262 isresistance to elongation. Specifically the spring 262 has no resistanceto bending. However, when the spring 262 encases the individual bulletelements in which the outer diameter of the bullets closely approximatesthe inner diameter of the spring 262, the spring 262 takes on theflexibility and bending characteristics of the bullet elements 220, 221,222, and 223 acting in concert. Specifically resistance to buckling is acharacteristic of the present invention. Furthermore, the amount anddirection of flexibility of the spring 262 will be determined by thedesign of the bullet elements comprising the inner tier or first layerof the invention. The composition and physical properties of the springfor resistance to elongation can be chosen to achieve the desiredresistance to elongation. The spring can be attached to the bullets atthe top and bottom of the stack.

The device according to another embodiment can have a third or outerlayer or tier. This layer is composed of a sleeve of suitable materialwoven 265 in the form of a Chinese finger trap. The material can befabric, metal, plastic or other suitable material. In FIG. 34, the wovenmaterial layer 265 is shown in the resting or neutral state of theinvention, where length is the shortest. The sleeve of woven material265 can be seen as loose and the outer layer is somewhat bulging. InFIG. 31 the sleeve of woven material 265 is seen with a tight weavepattern and the diameter has constricted and tightened to closelyapproximate the outer diameter of the spring 262. This tightening andconstriction imparts stiffness and rigidity when the invention iselongated. This phenomenon has been described in devices designed ascompression bandages, finger traction devices, and patient restraintdevices as disclosed in U.S. Pat. Nos. 1,268,932; 2,783,758; 3,872,861;4,728,329; 4,917,700; 5,027,802; 5,074,291; 5,451,203; and 5,649,541.The purpose of the third tier of the sleeve of woven material 265 is toprovide an absolute limit to the amount of elongation of the invention.This imparts a safety stop and reduces progressive wear of the spring262 since stretching beyond a certain point is prevented. At the sametime that the third tier elongates it constricts and reduces itsdiameter. This property is preferably conferred on the woven material265 by the weave pattern in the form of a Chinese finger trap. Thisconstriction of the woven material 265 tightly around the outside of thespring 262 provides a degree of stiffness and rigidity to the invention.Therefore with elongation of the invention as some of the rigidity islost by distraction and separation of the individual bullet elements220, 221, 222, and 223, a degree of rigidity is restored and reacquiredby the constricting action of the woven material 265. The sleeve can beattached to the bullets, the spring or both.

In this preferred embodiment, the dynamic spinal stabilization deviceaccording to the invention has three layers or tiers, arrangedconcentrically one within the other with the stacked bullets 220, 221,222, and 223 making up the first layer and the spring 262 making up thesecond layer and the woven material 265 making up the third layer. Otherembodiments and various arrangements of the layers would not depart fromspirit and scope of the invention.

A fourth layer could be applied consisting of a compression springaround the woven fabric 265 as shown in FIG. 31A. A balance in theresting state could be achieved between the extension spring 262 in thesecond layer with the compression spring 270 of the fourth layer. Theextension spring 262 can be preloaded with a small amount of elongation,maintained in the resting state by the compression spring 270. In thismanner some amount of flexibility would be permitted in the restingstate due to some degree of separation between the individual elementsof the first or inner most tier. With extension or backward bending ofthe patient's spine, the invention would be compressed between the headsof the pedicle screws 16 to which it is attached either directly orindirectly. With compression and shortening of the invention theindividual bullet elements 220, 221, 222, and 223 interlock with oneanother, and rigidity and resistance to buckling is provided. The fourthlayer spring can be attached to the sleeve, second tier spring, thebullets or any combination.

The dimensions of the dynamic spinal stabilization device as shown inthe figures are non limiting embodiments. Specifically, a typicaldimension is that of the terminal portions of the attachment elements231 and 232, which preferably correspond in diameter to commonly usedrigid rods in order to allow utilization with readily available andcommonly used pedicle screw systems. However, the inner aspect of eachattachment element 231 and 232 will be significantly larger in diameterdue to the presence of the attachment element collar 250 shown in FIG.31. The design, construction, and dimensions of the attachment elementcollar 250 will allow for the unified grouping of all three layers ortiers of the invention: the first tier comprised of the individualbullet elements 220, 221, 222, and 223 and bounded by the inner ormedial aspect of each attachment element; the second tier comprised ofthe extension spring 262; the third tier comprised of the woven material265 in the pattern of a Chinese finger trap; and optionally a fourthlayer comprised of a compression spring 270 as shown in FIG. 3A.

Several methods of surgical implantation of the present invention aredisclosed in FIGS. 47, 48 and 49. For illustrative purposes, onlymethods for providing dynamic stabilization are shown for three motionsegments involving four vertebral bodies L-3, L-4, L-5, S-1 shown as330, 332, 334, 336 in FIG. 47. A greater or lesser number of motionsegments of vertebra can be stabilized. Pedicle screw implants arewidely utilized by those skilled in the art, and several options arecommercially available, such as SCIENT'X and Medtronic(www.medtronic.com). This preferred embodiment contemplates eitherdirect or indirect attachment to these pedicle screws 216. FIG. 47reveals the technique of direct attachment to polyaxial pedicle screws216.

A multisegment dynamic spinal stabilization device constructed in serieswith multiple attachment elements is shown in FIG. 48. However, as thoseskilled in the art can readily appreciate, it would be difficult toestimate in advance the spacing required for the location of the variousattachment elements to enable fixation direct within the polyaxialpedicle screw heads, unless only one motion segment was beingstabilized. In order to employ the direct method for more than twopedicle screws, an assortment of varying lengths and spacing ofattachment elements would have to be available. In FIG. 47, as isobvious to those skilled in the art, the distance between the screwheads 216A in the L5 vertebral pedicle 334 and the screw head 16B of S1vertebral pedicle 336 is always very short, sometimes less than 1 cm. InFIGS. 48 and 49 the contour of the transverse rod 314 allows greaterdistance between screws 216A and 216B.

FIGS. 48 and 49 show a manner and method of indirect attachment topedicle screws employing intermediary transverse rods 254. A specialtype of contoured transverse rod 55 is attached between the S1 pediclescrews 251A and 251B. The concept of contoured transverse rod is verydifferent from the idea presented in U.S. Pat. Pub. No. 2006/0084991,since in the present invention the contour increases rather thandecreases the distance between the transverse rods. Furthermore thetransverse rods 254 and 255 in the present invention do not articulatedirectly with one another, either by means of a coupling joint or with acentral spacer. The transverse rods 254 and 255 utilized in the presentinvention are a standard type rod commonly utilized in commerciallyavailable fusion instrumentation systems such as pedicle screws and rodimplants manufactured by SCIENT'X and/or Medtronic. The indirect methodof use and implantation described herein for the present inventionprovides three advantages over the direct method as seen in FIG. 47. Theindividual dynamic spinal stabilization devices are utilized even whenproviding dynamic stabilization to multiple spinal motion segments. Thetransverse rods have the ability to increase the distance between theattachment points of the L5 and S1 vertebral bodies. This isaccomplished by the contoured intermediary rod 255. This increaseddistance allows for implantation of a longer dynamic spinalstabilization device 282, with the result that the implanted inventionhas increased flexibility characteristics thereby improving the dynamicstabilization between the L5 and S1 vertebrae. The indirect methodprovides increased inherent stability of the entire construct as aresult of the transverse rods 254 and 255 themselves, with the resultantload sharing between both pedicle screws 216 of each vertebra. A furtherbenefit is the inherently greater stability to rotation provided bylocating the dynamic spinal stabilization device 282 further from themidline of the vertebra.

The dynamic spinal stabilization device may be implanted utilizingeither the direct or indirect method of attachment to pedicle screws216. In either method implantation may occur with the flexible rod 282in the resting state of minimum length, or implanted at a length that isintermediate between its minimum and maximum length. The mostadvantageous strategy would be employed on an individual basis and wouldbe predicated on the position of the spinal bones at the moment ofsurgical implantation. For example if the patient is positioned on theoperating table with the spine in full or nearly full extension, thenobviously no additional extension would be desirable afterwards. In thatcircumstance the dynamic spinal stabilization device 282 would beimplanted in its resting state of minimal length. On the other hand, ifsome additional spinal extension is judged to be desirable aftersurgery, than the dynamic spinal stabilization device can be implantedin an intermediate length. The amount and degree of allowable movementcould be readily ascertained during the surgical procedure by varyingthe distance between the transverse rods 254 (for the indirect method)or between the pedicle screw heads 216 (for the direct method). Analternative to loading the preferred embodiment of the flexible rod 282in some tension and partial elongation, another embodiment of thedynamic spinal stabilization device can be implanted. As mentionedearlier another embodiment is constructed with four rather than threetiers. The fourth or outer most tier in this embodiment is a compressionspring 270. The characteristics of this spring 270 would becomplimentary to the extension spring 262 located in the second tier.The result of the combined and balanced but opposing forces of these twosprings is that the resting or neutral state of the device would be ofan intermediate length, neither in complete compression nor in fullelongation. This would enable some degree of spinal extension when thedynamic spinal stabilization device 282 was implanted in its neutral orresting state.

The connectors 284 utilized for the attachment at either end of thedynamic spinal stabilization device 282 to the transverse rods can be ofvarious designs. One example of such a connector is disclosed by U.S.Pat. No. 5,474,551 and U.S. RE39,035 E.

A method and apparatus for attachment of the dynamic spinalstabilization device is presented in FIGS. 50 through 55. Paired plates290 and 292 are attached to the spinous processes 302 of the vertebrainstead of directly to pedicle screws or indirectly via transverse rods.The spinous process attachment device is composed of paired plates 290and 292 as seen in FIGS. 50 and 291 and 292 as seen in FIG. 51. The boneof the spinous process 302 is sandwiched between the plates 290 and 292,which are affixed to the spinous process by an attachment means such asa clasp, hook, interlocking elements or by a looped cable 310 such as abraided titanium cable. The inner surfaces of the plates can beroughened or have spike like projections 260 to grip and/or attach tothe surface of the bone. If a cable is used to secure the plates,notches 312 can be fashioned in the plates 290, 292 to allow for secureseating of the braided titanium cable 310. The cables are commerciallyavailable and are commonly in use by those skilled in the art. Theplates 290, 292 have short side projecting rods 264 or other attachmentmeans to connect to the dynamic spinal stabilization device. FIG. 51shows a variation of the plate design that is constructed with two pairof side projecting rods 223, which is also demonstrated in the centerplate of FIG. 55. FIG. 51 also reveals another design variation which isthe ability to pass the braided titanium cable through holes 314 withinthe plates, and if desired, though the substance of the bony spinousprocess 302 itself rather than on either side of it, in order to tightenand bind the plates tightly to the bony surface. The plates can beconstructed of durable material suitable for implantation such astitanium. The paired plates 290, 292 are sized and shaped to fit on thespinous process. The spinous process typically has a thickness of 8 mmand a height of 25 mm. The plates can be sized 25-50 mm with a width of3-6 mm.

The dynamic spinal stabilization device 268 is attached to the sideprojecting rods 264 using attachment means 316. Bumper or spacerelements 267 are attached to and positioned at the bottom or top of thepaired plates between adjacent spinous processes. The bumper or spacerelements can be fabricated from a material having a low coefficient offriction such as UHMWPE or PEEK, or any other suitable substance. Thebumper elements 267 are wide enough to attach to the paired plates orapproximately 15-20 mm. The distance between the adjacent spinousprocess is typically 2-5 cm and the bumpers are sized to fit betweenadjacent spinous processes.

The dynamic spinal stabilization device 268, when attached to the pairof plates 290, 292 affixed to the spinous processes 302 willadvantageously resist excessive spinal flexion. Loss of the normallordotic curve by simple distraction between the spinous processes 302by a bumper or spacer element 267 alone may lead to flat back syndrome,kyphosis, and potentially exacerbation of a pre-existingspondylolisthesis. However the addition of the flexible rod of thepresent invention will function to counteract these undesirabletendencies. Nonetheless, controlled spinal flexion will be permitted bythe dynamic spinal stabilization device.

1-16. (canceled)
 17. An apparatus for stabilizing a patient's spinecomprising: a plurality of bullets with each bullet having an upper sideand a lower side wherein the bullet's upper side is sized and configuredto insert into an adjacent bullet's lower side in a manner forming arod; wherein, a top bullet is on the top of the rod and a bottom bulletis on the bottom of the rod; an extension spring that resists elongationwherein said extension spring is disposed around and encases the rod andthe extension spring is attached to the rod in a manner to resistseparation of the individual bullets; wherein, upon elongation of theextension spring, the bullets' upper sides withdraw from the adjacentbullets' lower sides allowing the bullets to move and bend in all planeswith respect to the adjacent bullets; wherein, the top bullet isattached to a part of a patient's spine by an attachment means and thebottom bullet is attached to a second part of the patient's spine by anattachment means.
 18. The apparatus for stabilizing a patient's spine ofclaim 17, wherein each bullet is attached to the adjacent bullet by aflexible attachment material to flexibly attach the bullets together ina manner to provide for terminal elongation of the rod; furthercomprising a top attachment element attached to the top bullet; a bottomattachment element attached to the lower bullet.
 19. The apparatus forstabilizing a patient's spine of claim 17, wherein, the bullets' uppersides are conically shaped. 20-22. (canceled)
 23. The apparatus forstabilizing a patient's spine of claim 17, further comprising; a sleeveof woven material disposed around and encases the extension spring in amanner that provides an elongation limit to the spring; and wherein, thesleeve is in a loose weave pattern when the extension spring is in aresting, non elongated state and upon elongation of the extensionspring, the sleeve elongates, tightening the sleeve's woven materialresulting in a constricted diameter of the sleeve.
 24. The apparatus forstabilizing a patient's spine of claim 23, further comprising: acompression spring disposed around and encases the sleeve of wovenmaterial and bullets in a manner to resist compression of the bulletswith respect to each other.
 25. The apparatus for stabilizing apatient's spine of claim 17, wherein, the bullets have a generallyuniform lateral curved shape in a manner that forms a curved rod shape.26. The apparatus for stabilizing a patient's spine of claim 17, furthercomprising: a guide wire; wherein, the bullets have a central passagedisposed from the bullet's top side to the bullet's bottom side with thepassage sized for insertion of the central guide wire with the centralguide wire disposed through the bullets' aligned central passages. 27.The apparatus for stabilizing a patient's spine of claim 17, wherein theattachment means to connect the bullets to the spine comprises a firsttransverse rod and second transverse rod with each transverse rod havinga first end and second end and a midbody wherein the top bullet isattached to the midbody of the first transverse rod and the first end ofthe first transverse rod is attached to a part of the patient's spineand the second end of the first transverse rod is attached to a secondpart of the patient's spine and the bottom bullet is attached to themidbody of the second transverse rod wherein first end of the secondtransverse rod is attached to a third part of the patient's spine andthe second end of the second transverse rod is attached to a fourth partof the patient's spine.
 28. The apparatus for stabilizing a patient'sspine of claim 27, wherein, at least one of the transverse rods isshaped and attached to one of the bullets in a manner that the distancebetween the first end of the first rod and the first end of the secondrod is less than the length of the interconnected bullets.
 29. Theapparatus for stabilizing a patient's spine of claim 17, wherein, theattachment means that attaches the rod to the spine comprises a firstplate and a second plate with each plate having a midbody and the firstplate and second plate are attached a patient's spine.
 30. The apparatusfor stabilizing a patient's spine of claim 29 further comprising: afirst bumper attached to the first plate; a third plate and a fourthplate; a second bumper attached to the third plate; wherein the thirdplate and fourth plate are attached to an adjacent spinous process;wherein the first bumper and second bumper fit snugly adjacent to eachother.
 31. An apparatus for stabilizing a patient's spine comprising: aplurality of interconnected bullets with each bullet having an upperside and lower side wherein the lower bullets' lower sides are sized andconfigured to allow insertion of an adjacent bullet's upper side in aninterconnected manner forming a stack of bullets in a rod shape and saidstack of bullets are generally rigid and resist bending when each of thebullet's upper side is fully inserted into adjacent bullet's lower side;a spring that resists elongation is disposed around the stack of bulletsand said spring encases and is attached to the stack of bullets in amanner to resist separation of the stack of bullets and promotesrigidity of the stack of bullets; wherein, upon elongation of thespring, the bullet's upper side withdraws from the adjacent bullet'slower side allowing the stacked bullets to move and bend with respect tothe adjacent bullets; a sleeve of woven material that encases the springin a loose weave pattern when the spring is in a resting state with thebullets stacked in a full insertion and rigid manner and when the springis elongated the sleeve's weave pattern tightens resulting in aconstricted diameter and wherein the sleeve is attached to the spring orto at least one of the bullets in a manner to provide an absolute limiton the spring's elongation and imparting some rigidity to the stackedbullets and spring.
 32. The apparatus for stabilizing a patient's spineof claim 31, wherein, the bullets have a central passage disposed fromthe bullet's top side to the bullet's bottom side and said centralpassage is sized for placement of a central guide wire; a compressionspring that encases the sleeve of woven fabric and the compressionspring is attached to the stack of bullets in a manner that resistscompression of the bullets with respect to each other; 33-36. (canceled)37. An apparatus for stabilizing a patient's spine, comprising: aplurality of bullets with each bullet having an upper side and a lowerside, wherein the bullet's upper side is sized and configured to insertinto an adjacent bullet's lower side to form a rod; wherein, a topbullet is on a top of the rod and a bottom bullet is on a bottom of therod; a spring that resists elongation wherein said spring is disposedaround and encases the rod and the spring is attached to the rod toresist separation of the individual bullets; wherein, upon elongation ofthe spring, a bullet's upper side withdraws from an adjacent bullet'slower side, allowing each bullet to move and bend with respect to theadjacent bullet; wherein, the top bullet is attached to a first part ofa patient's spine and the bottom bullet is attached to a second part ofthe patient's spine; and wherein each bullet is attached to the adjacentbullet by a flexible material to flexibly attach the bullets together toprovide for elongation of the rod.
 38. The apparatus for stabilizing apatient's spine of claim 37, further comprising; a sleeve of wovenmaterial disposed around and encases the spring to provide an elongationlimit to the spring; and wherein, the sleeve is in a loose weave patternwhen the spring is in a resting, non elongated state, and uponelongation of the spring, the sleeve elongates, tightening the sleeve'swoven material resulting in a constricted diameter of the sleeve. 39.The apparatus for stabilizing a patient's spine of claim 38, furthercomprising: a compression spring disposed around and encases the sleeveof woven material and bullets in a manner to resist compression of thebullets with respect to each other.
 40. The apparatus for stabilizing apatient's spine of claim 37, further comprising: a guide wire; whereinthe bullets have a central passage disposed from the bullet's top sideto the bullet's bottom side with the passage sized for insertion of thecentral guide wire disposed through the bullets' aligned centralpassages.
 41. The apparatus for stabilizing a patient's spine of claim37, further comprising: an attachment device to connect the bullets tothe spine comprises a first transverse rod and second transverse rodwith each transverse rod having a first end and second end and amidbody, wherein the top bullet is attached to the midbody of the firsttransverse rod and the first end of the first transverse rod is attachedto a part of the patient's spine and the second end of the firsttransverse rod is attached to a second part of the patient's spine, andthe bottom bullet is attached to the midbody of the second transverserod wherein first end of the second transverse rod is attached to athird part of the patient's spine and the second end of the secondtransverse rod is attached to a fourth part of the patient's spine. 42.The apparatus for stabilizing a patient's spine of claim 41, wherein atleast one of the transverse rods is shaped and attached to one of thebullets such that a distance between the first end of the first rod andthe first end of the second rod is less than a length of theinterconnected bullets.
 43. The apparatus for stabilizing a patient'sspine of claim 37, further comprising: an attachment device forattaching the rod to the spine, including a first plate and a secondplate with each plate having a midbody and the first plate and secondplate are attached a patient's spine.